Ober, Kaler, Grimes & Shriver, A Professional Corporation  
Ober|Kaler Health Law Alert - Spring 2005




In this Issue

From the Chair

Congratulations

Guide to Terms

Ober|Kaler in Print

OIG Activity
OIG Approves Six Gainsharing Arrangements

OIG Advisory Opinions

OIG 2005 Work Plan

CMS Developments
CMS Proposes Plan to Pay Unpaid Costs of Emergency Health Care

Trailblazer Fraud Alert Reveals Provider Identity Theft

Long Term Care
Discerning the New Pressure Ulcer Guidelines

Pharma
TAP Pharmaceuticals Settles with Lupron Consumers

Hospitals
Pay for Performance: Will Your Hospital Be Ready?

Nonphysician Practitioners
"Incident To" Rule Changes

Compliance
OIG Finalizes Supplemental Hospital Compliance Guidance

OIG's Supplemental Hospital CPG Looks at Hospital-based Physicians

OIG/AHLA Release Second Compliance Resource

Reimbursement
IRF "75 Percent Rule" Blocked

Correct Minor Errors and Omissions Without Appeals

Self-referral
Hospitals Meet "Under-development"

FCA
Courts Apply Strict Interpretation of Officer or Employee Under FCA

Lack of Pharmaceutical Recycling Guidance Precludes FCA Liability

Questionable Incentive Program Raises FCA Liability

Enforcement
Supreme Court Declares Sentencing Guidelines "Advisory"

Tax
IRS Penalizes Health System for PAC/Payroll Deduction Plan

Antitrust
DOJ/FTC Report on Antitrust in Health Care

Physican Focus
Physician Retention Arrangements: Stark and Antikickback Issues

Employment
Alien Certification Exemption to Avert Staffing Crisis

 

OIG/AHLA Release Second Compliance Resource

Michele M. Vicente, CLA
Paralegal

The OIG and American Health Lawyers Association (AHLA) joined forces again in 2004 to compile a second educational resource, An Integrated Approach to Corporate Compliance, as a supplement to the compliance resource on which the OIG and AHLA collaborated in 2003, Corporate Responsibility and Corporate Compliance: A Resource for Health Care Boards of Directors. Developed in response to legal developments relating to corporate responsibility and lawyers' professional ethics, modifications to the Federal Sentencing Guidelines, and the recommendations of the American Bar Association Task Force on Corporate Responsibility, the supplemental educational resource examines "the interplay in the roles of the General Counsel and the Chief Compliance Officer in supporting the Board's compliance oversight responsibilities." The resource is intended to assist directors in establishing and coordinating their respective roles and responsibilities in conjunction with the organization's general counsel and chief compliance officer in terms of compliance plan management.

The resource compares the critical role of the general counsel in advising the board with respect to understanding relevant laws and regulations and analyzing the associated business risks, to the equally vital role of the chief compliance officer in promoting the compliance oversight functions of the board through management of the day-to-day operations of the compliance program. The resource suggests that increasing regulation and strenuous enforcement activity in the health care industry have caused the roles of the general counsel and chief compliance officer in supporting the compliance oversight function of a health care organization's board to be more complex than those in any other industry sector.

According to the resource, it is important that the board understand how the general counsel's and chief compliance officer's roles are integrated in the implementation of the organization's compliance program. Further, the board must demand, and receive, assurances that appropriate processes are in place to provide the board with timely, candid, and appropriate information and assessments with respect to the compliance program. To that end, the resource offers a number of questions, with commentary, that boards may consider:

  1. To what extent is the General Counsel utilized by the Board to provide relevant advice regarding compliance matters?

  2. Where and how is the General Counsel involved in each of the fundamental elements of the compliance program?

  3. How does the General Counsel receive notice of, and provide input on, the organization's response to identified or suspect compliance failures?

  4. What are the roles of the organization's Chief Compliance Officer and General Counsel in operating the corporate compliance program? Who has responsibility for reporting to the Board on compliance matters?

  5. How is the Board notified when there are disagreements among management, the Chief Compliance Officer and/or the General Counsel relating to the organizational response to specific compliance matters?

  6. Does the Board understand how the organization utilizes the attorney/ client and work product privileges when responding to third party requests for information?

  7. Are processes in place to enable the General Counsel to bring issues of legal compliance to the appropriate authorities within the organization?

Finally, the resource presents a number of considerations for a system of checks and balances between the general counsel and compliance officer to further the organization's compliance program objectives and program oversight. The administrative processes may vary according to the relationship between the general counsel and compliance officer. For example, the resource suggests that, in organizations in which the general counsel serves as the compliance officer, boards might consider adopting a recusal process by which the general counsel could recuse him- or herself from a compliance investigation if the matter might implicate the general counsel. When an organization's compliance officer is separate from, but reports to, the general counsel, the board might consider establishing a formal alternative reporting process by which the compliance officer may report directly to another member of senior management if the compliance officer deems such reporting to be necessary. Alternatively, if the compliance officer is separate from and does not report to the general counsel, the resources suggests the board consider involving the general counsel in periodic risk assessments, reviews of proposed policies and reports on compliance processes, and devising remedial measures to address violations.

Like compliance programs themselves, following suggestions in the resource is not mandatory and does not provide any guarantees that problems will not arise. Doing so, however, will demonstrate that the board has made a good faith effort to fulfill its compliance oversight responsibilities.

The OIG/AHLA compliance resource, An Integrated Approach to Corporate Compliance: A Resource for Health Care Organization Boards of Directors, is available on the OIG's website at:

www.oig.hhs.gov/fraud/docs/complianceguidance/Tab%204E%20Appendx-Final.pdf.

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